BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 9328753 · Received November 15, 2019

    Report

    Report Number
    3005985723-2019-00811
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    October 29, 2019
    Report Date
    January 20, 2022
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT SEAL BROKEN ON SAW ATTACHMENT. FLUID LEAKED OUT CASE TYPE: TKA. SURGICAL DELAY: 15 MINUTES. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS NOT EVALUATED AS THE PRODUCT WAS UNAVAILABLE FOR INSPECTION. CAPA 2127499 HAS BEEN RAISED FOR THE SAME. PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 09/01/2016 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212186, LOT 35020816 SHOWS 4 ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINTS ARE PR: 2215504, 2243601, 2243622, 2243628. CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. H3 : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT SEAL BROKEN ON SAW ATTACHMENT. FLUID LEAKED OUT . CASE TYPE: TKA. SURGICAL DELAY: X <= 15 MINUTES. PRODUCT EVALUATION AND RESULTS: FUNCTIONAL INSPECTION - RATCHETING MECHANISM BROKEN. FAILURE IS CONFIRMED. PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS SHOWS 5 ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE IS CONFIRMED VIA INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    SEAL BROKEN ON SAW ATTACHMENT. FLUID LEAKED OUT. CASE TYPE: TKA. SURGICAL DELAY: 15 MINUTES. UPDATE: WAS ANY DEBRIS LEFT INSIDE THE PATIENT? NO. DID THE BLADE BECOME ATTACHED? NO.

    Description of Event or Problem · 0

    SEAL BROKEN ON SAW ATTACHMENT. FLUID LEAKED OUT ; CASE TYPE: TKA; SURGICAL DELAY: X <= 15 MINUTES; UPDATE: WAS ANY DEBRIS LEFT INSIDE THE PATIENT? NO. DID THE BLADE BECOME ATTACHED? NO.

    Additional Manufacturer Narrative · 1

    AS PART OF THE NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    SEAL BROKEN ON SAW ATTACHMENT. FLUID LEAKED OUT. CASE TYPE: TKA. SURGICAL DELAY: 15 MINUTES. UPDATE: WAS ANY DEBRIS LEFT INSIDE THE PATIENT? NO. DID THE BLADE BECOME ATTACHED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124679 2.7 DEGREE STRAIGHT SAGITAL SAW ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 212186 3500269 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| H